Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes - Full Text View

Purpose

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Condition	Intervention	Phase
Diabetes Mellitus Chronic Kidney Disease	Drug: rosuvastatin	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:

An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure [ Time Frame: 72 h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes. [ Time Frame: 30 d ] [ Designated as safety issue: Yes ]


Enrollment:	2998
Study Start Date:	December 2008
Study Completion Date:	November 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 perioperative rosuvastatin administration for at least 5 dosages	Drug: rosuvastatin rosuvastatin
Placebo Comparator: control blank control of perioperative statin administration	Drug: rosuvastatin rosuvastatin

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Planned diagnostic coronary or peripheral artery angiography
T2DM
CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
Statin naive, or not on statin treatment for at least 14 days
Withdrawal metformin or aminophylline for 48h before angiography
Total iodixanol volume

Exclusion Criteria:

Hypersensitivity to iodine-containing compounds and statins
Type 1 diabetes mellitus
Ketoacidosis
Lactic acidosis
CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR＜30ml/min per 1.73m2)
STEMI
NYHA class IV or hemodynamic instability
Administration of any iodinated CM within 14 days before randomization
LDL-C＜1.82mmol/L（70mg/dL）
Hepatic dysfunction (ALT 3 times greater than upper normal limit)
Thyreoid insufficiency
renal artery Stenosis(unilateral ＞70％ or bilateral stenosis＞50％)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786136

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Sponsors and Collaborators

Shenyang Northern Hospital

Investigators


Principal Investigator:	Yaling Han, MD	Shenyang Northern Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Li J, Li Y, Wang X, Yang S, Gao C, Zhang Z, Yang C, Jing Q, Wang S, Ma Y, Wang Z, Liang Y, Han Y. Age, estimated glomerular filtration rate and ejection fraction score predicts contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease: insight from the TRACK-D study. Chin Med J (Engl). 2014;127(12):2332-6.

Han Y, Zhu G, Han L, Hou F, Huang W, Liu H, Gan J, Jiang T, Li X, Wang W, Ding S, Jia S, Shen W, Wang D, Sun L, Qiu J, Wang X, Li Y, Deng J, Li J, Xu K, Xu B, Mehran R, Huo Y. Short-term rosuvastatin therapy for prevention of contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease. J Am Coll Cardiol. 2014 Jan 7-14;63(1):62-70. doi: 10.1016/j.jacc.2013.09.017. Epub 2013 Sep 26.


Responsible Party:	Han Yaling, MD, vice president, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:	NCT00786136 History of Changes
Other Study ID Numbers:	SYNH-20081028
Study First Received:	November 5, 2008
Last Updated:	April 9, 2013
Health Authority:	China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:


diabetes mellitus chronic kidney disease contrast induced acute kidney injury angiography

Additional relevant MeSH terms:


Diabetes Mellitus Kidney Diseases Renal Insufficiency, Chronic Acute Kidney Injury Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency	Rosuvastatin Calcium Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 26, 2016

Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes (TRACK-D)